Senior Director
4 weeks ago
The Senior Director overseeing Drug Product Development will lead the integration and supervision of all aspects of product development, encompassing pre-formulation sciences, formulation development, device development, and packaging development. A key responsibility will be the identification and management of Contract Manufacturing Organization (CMO) sites for clinical manufacturing and commercial preparation, which is crucial for maintaining an integrated vendor strategy supporting the portfolio. The successful candidate will collaborate closely with counterparts in Chemical Development, Analytical Development, and Clinical Supply Chain within the CMC (Chemistry, Manufacturing, and Controls) domain and other cross-functional departments in research and development.
Responsibilities:
- Offer scientific, strategic, and practical guidance across the entire spectrum of pharmaceutical drug product development, covering pre-formulation, formulation development, non-clinical and clinical manufacturing, and preparations for commercialization.
- Establish strategies tailored to each development phase for small molecule drug products, select an appropriate drug delivery platform, and engage in manufacturing processes aligned with preclinical, clinical, and market image development requirements.
- Identify and provide a technical recommendation for selecting drug product formulation development and manufacturing vendors with the required capabilities. Coordinate closely with analytical development on these decisions.
- Build relationships and lead outsourced drug product development and manufacturing activities, including contracts, timelines, and budgets, to meet overall project timelines.
- Collaborate with internal and external CMC functions, including project management, chemical development, analytical development, and supply chain, to align priorities and project timelines. Communicate progress regularly and effectively, addressing any queries and managing any escalations.
- Maximize product development technical capability, formulation development, and expertise internally by leveraging CDMO partners.
- Troubleshoot formulation and manufacturing issues as needed.
- Participate in cross-functional development teams as needed; represent Drug Product Development on CMC sub teams.
- Serve as CMC lead for programs in clinical development, driving the overall CMC strategy.
- Author, review, and approve the relevant CMC sections for US and ex-US regulatory filings.
- Work with quality assurance (QA) to manage the release of GMP drug products and resolve technical issues or deviations.
- Review and approve master batch records, validation protocols/reports, specifications required for drug product manufacturing, and author development/technical reports.
Requirements:
- Ph.D. with 10+ years of experience or BS/MS with 15+ years of experience in CMC pharmaceutical sciences or closely related discipline with relevant small molecule development experience.
- Strong knowledge and implementation of ICH Guidelines and current Good Manufacturing Practices (cGMPs).
- Strong expertise in pre-formulation, API solid-state properties, standard and exotic/novel excipients, and the potential impact on drug product manufacturing and performance.
- Ability to manage multiple projects spanning all phases of development and rapidly adapt to changing program needs.
- Strong track record in drug product development, CDMO management, and large-scale manufacturing.
- Experience in multiple drug delivery platforms such as solid oral dosage forms, injectables, and inhalation products.
- Highly experienced with FDA, EU, and CMC regulatory submissions
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